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Aminophylline Tablets Bp 100 Mg

PRESENTATION:
Aminophylline Tablets BP 100mg: White, circular, flat bevelled-edge tablet plain on both sides. Each tablet contains: Aminophylline BP 100mg.

CLINICAL PHARMACOLOGY:
Aminophylline is a bronchodilator. Aminophylline relaxes bronchial smooth muscle, relieves bronchospasm, and has a stimulant effect on respiration. It stimulates the myocardium and central nervous system, decreases peripheral resistance and venous pressure, and causes diuresis.

Pharmacokinetics
:
Aminophylline, a complex of theophylline with ethylenediamine, readily liberates theophylline in the body. Aminophylline is rapidly and completely absorbed; the rate, but not the extent of absorption is decreased by food and food may also affect Aminophylline clearance. Aminophylline is approximately 40% bound to plasma proteins, but in neonates, or adults with liver disease, binding is reduced. Optimum therapeutic serum concentrations are generally considered to range from 10 to 20mg/mL (55 to 110mmol per litre) although some consider a lower range appropriate. Aminophylline is metabolised in the liver to 1,3-dimethyluric acid, 1-methyluric acid, and 3-methylxanthine. These metabolites are excreted in the urine. The serum half-life of Aminophylline in an otherwise healthy, non-smoking asthmatic adult is 6 to 12 hours, in children 1 to 5 hours,  in cigarette smokers 4 to 5 hours, and in neonates and premature infants 10 to 45 hours. The serum half-life of Aminophylline may be increased in the elderly and in patients with heart failure or liver disease. Aminophylline crosses the placenta; it also enters breast milk.

USES:
Aminophylline is used in the management of asthma and chronic obstructive pulmonary disease.

DOSAGE   AND   ADMINISTRATION:
Acute bronchospasm: 100 to 300 mg three or four times daily after food.

CONTRA-INDICATIONS AND  WARNINGS:
Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy. Aminophylline should also be given with caution to patients with heart failure, hepatic dysfunction or chronic alcoholism, acute febrile illness, and to neonates and the elderly.

Adverse Effects:
The adverse effects commonly encountered are gastro-intestinal irritation and stimulation of the CNS. Aminophylline may cause nausea, vomiting, abdominal pain, diarrhoea, other gastro-intestinal disturbances, insomnia, headache, anxiety, restlessness, dizziness, tremor and palpitations.

Overdosage:
After Aminophylline overdosage by mouth, the stomach should be emptied by emesis or lavage. Elimination may be enhanced by repeated oral doses of activated charcoal.

Interactions:
Concomitant use with other xanthine medications should be avoided. Aminophylline clearance may by reduced by interactions with other drugs including allopurinol, some antiarrhythmics, cimetidine, disulfiram, fluroxamine, interferon alfa, macrolide antibiotics and quinolones, oral contraceptives, thiabendazole and viloxazine, necessitating dosage reduction. Phenytoin and some other anticonvulsants, the antiviral ritonavir, rifampicin, sulphinpyrazone and cigarette smoking may increase aminophylline clearance, necessitating an increase in dose or dosing requency.

PHARMACEUTICAL   PRECAUTIONS:
Store in a cool, dry place. Protect from light. Keep out of reach of children.

LEGAL   CATEGORY:
Prescription Only Medicine (POM)           
Ref. No.: INS196/.06.02

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